- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133831
Don't Throw Your Heart Away: Layperson Study 1
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Publicly available outcome assessments for transplant programs do not make salient that some programs tend to reject many of the hearts they are offered, whereas other programs accept a broader range of donor offers. The investigators use empirical studies to test whether transplant center performance data (i.e. transplant and waitlist outcome statistics) that reflect center donor acceptance rates influence laypersons to evaluate centers with high organ decline rates less favorably than centers with low organ decline rates. 1000 lay participants will be recruited from Amazon Mechanical Turk and randomized to one of five different information presentation conditions:
- Condition 1 ("baseline" condition): view only combined transplant survival (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center)
- Condition 2: view combined transplant survival + total survival (e.g. overall survival rate at each center, computed from survival rates of both transplant and waitlist patients)
- Condition 3: view only stratified transplant survival (e.g. transplant survival rate stratified into patients who received excellent donor organs and patients who received less than optimal donor organs)
- Condition 4: view stratified transplant survival + total survival
- Condition 5: view only total survival
Participants will be given an introduction to the donor organ match process, then asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose between two hospitals: one hospital with an non-selective, "accepting" strategy (takes all donor heart offers), and one hospital with a more selective, "cherrypicking" strategy (tends to reject donor offers that are less than "excellent" quality). In order to identify the decision process that underlies this choice pattern, the investigators will examine a putative mediator. Specifically, participants will be asked to rate the extent to which they considered patients' chances of getting an excellent heart, avoiding a less-than-optimal heart, and getting any type of heart when making their choice between the two hospitals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Carnegie Mellon University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants who are already qualified mTurk workers with Worker Accounts meeting the above criteria will be asked to participate if they confirm the following inclusion criteria in the consent form.
- 18 years of age or older
- must read and understand the information in the consent form
- must want to participate in the research and continue with the survey
- must live in United States
Exclusion Criteria:
- Participants on mTurk will not be allowed to participate if they fail to pass the initial "bot screening", a multiple-choice question that asks, "What phone number should you dial when there is an emergency?" The obvious correct response in this screening question is "911", so participants who select one of the incorrect responses (i.e. "1-800-ANTIBOT", "1-877-MTURKER", "123") are filtered out and not allowed to complete the survey.
- Participants on mTurk will be allowed to participate, but excluded from data analysis, if they submit a nonsense response to the free-response question which reads, "In your own words, why do you think patients should choose the hospital you picked?" This question takes place after the participant has viewed the choice stimuli and selected their response. If participants input nonsense in the text response box, they will be permitted to complete the survey and paid, but filtered out from the data analysis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Condition 1: Combined only
Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g.
transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.
|
|
|
Experimental: Condition 2: Combined plus Total
Participants randomized to Condition 2 will view combined transplant survival and total survival outcome information when making a choice between the two hospitals.
|
The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: [(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)] / [number of patients alive on waitlist at start of year]. |
|
Experimental: Condition 3: Stratified only
Participants randomized to Condition 3 will view only stratified transplant survival outcome information when making a choice between the two hospitals.
|
The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant] |
|
Experimental: Condition 4: Stratified plus Total
Participants randomized to Condition 4 will view stratified transplant survival and total survival outcome information when making a choice between the two hospitals.
|
The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: [(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)] / [number of patients alive on waitlist at start of year]. The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant] |
|
Experimental: Condition 5: Total only
Participants randomized to Condition 5 will view only total survival outcome information when making a choice between the two hospitals.
|
The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: [(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)] / [number of patients alive on waitlist at start of year]. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Choice
Time Frame: 1 day
|
The outcome variable will be a measure of binary choice between two hospitals: one with a selective donor-heart acceptance strategy and one with a non-selective donor heart acceptance strategy. Participants will respond to the question "Which Hospital is a better choice for patients? Please click on one of the two tables below to indicate which hospital is the better choice." Participants will choose been two outcome tables featuring the selective and non-selective hospital (counterbalanced, such that each of the two choices is equally likely to be presented at top of the choice scenario in each condition). The number of participants that choose each hospital will be the measured outcome variable used in analyses. |
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mediator of Hospital Choice
Time Frame: 1 day
|
Participants responded to the question, "There are many reasons why one transplant hospital might outperform another.
Which reasons were most important in your decision?
Please move the slider to indicate how much you considered each of the reasons below (0=reason was not important, 100=reason was extremely important).
Patients were more likely to receive any type of donor heart at the hospital I picked.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alison E Butler, BS, Carnegie Mellon University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1 F30 HL152526-01-A
- 20PRE35120492 (Other Grant/Funding Number: American Heart Association)
- 1F30HL152526-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The PI will make all of the raw IPD files - together with statistical analysis protocol descriptions and information for proper analysis available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts. All human subjects data are anonymized immediately when they are initially written from the online survey platform to the server, and thus participant confidentiality will not be compromised by this plan for data sharing.
All hypotheses, methods, and planned analyses for the applicant's studies will be pre-registered on ClinicalTrials.gov and Open Science Framework.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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